13 
for the acronym "DNA." The working group agreed this was a reasonable modifi- 
cation of the language of this section. 
Dr. Walters then called the attention of the working group to Section I-B-2-a- ( 2 ) . 
This section requests information on the efficiency of vector insertion in target 
cells . 
Dr. Temin said this language as written addresses efficiency in a narrow sense. 
He said this section should ask: how many cells have taken up and integrated 
the vector DNA; how many of these cells have DNA rearrangements; and how marry of 
these cells are expressing the insert DNA. 
Dr. Walters asked if Cars . Temin and Anderson would compose language for this 
section of the document. 
Dr. Walters called the attention of the working group to Section I-B-2-c-(l) 
of the document. 
Dr. Grobstein thought the word "particularly" should be substituted for the 
word "specifically" in Section I-B-2-c-( l)-(d) . The working group agreed. 
Dr. Motulsky noted that some comments had been received concerning Section 
I-B-2-c-( l)-(e) of the document; in response to these comments, he suggested 
the working group delete the phrase "non-human primates" and substitute 
the word "animal." 
Dr. Anderson said valid reasons exist for requiring primate testing; i.e., the 
endogenous retroviruses present in other animals differ from those present in 
primates. He argued that this language should not be deleted frcm the points 
to consider document. Dr. Temin said the requirement for primate testing is an 
important one; primates are the best model systan . 
Dr. Motulsky asked how long the tested primates will be followed. Dr. Anderson 
said the primates need only be observed for acute effects. He said seme research 
centers are testing animal models other than primates. He felt data generated 
by these test systems supplemented with other appropriate data would be adequate. 
Dr. Grobstein felt deleting at this time the language requiring primate testing 
could stir controversy. He thought this language should renain in the document 
since it does not require such testing be part of the submission, but simply 
asks that such data be supplied if it exists. Dr. Anderson thought the document 
indicates primate testing data should be submitted, or a reasonable justification 
should be given as to why such data were not included . The need to treat a 
very sick child is a valid justification. 
Dr. Temin suggested the working group could add the words "and/or other animals" 
to Section I-B-2-c-( l)-(e) . Dr. Anderson supported this suggestion. 
Dr. Motulsky suggested the language should read "animals including norihuman 
primates." Dr. Temin thought the language proposed by Dr. Motulsky more 
strongly specified testing in primates. Dr. Anderson preferred the language 
[ 98 ] 
